Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)

Completed

Conditions studied: SARS-CoV-2, Covid19

In brief

Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.

Key facts

Study ID

NCT04750629

Run by

Lumos Diagnostics

People needed

140

Starts

2021-02-08

Expected to finish

2021-05-14

Last updated by the study team

2021-06-18

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection
• First onset of COVID-19-like symptoms within the last 5 days
• ≥ 1 year of age
• Signed Informed Consent

You may not qualify if…

• Unable or unwilling to provide signed, Informed Consent
• Less than 1 year of age
• SARS-Cov-2 RT-PCR collection that occurred > 3 hours from CoviDx Rapid Antigen Swab collection
• First onset of COVID-19-like symptoms occurring more than 5 days from study visit
• Invalid or missing PCR test results
• Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study)
• Enrollment in another study involving the collection of a nasopharyngeal or nasal swab
• Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study

Where it is running

• Doral Medical Research — Hialeah, Florida, United States
• Comprehensive Clinical Research — West Palm Beach, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.